CAR T Warehouse Change Control Analyst

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Documentation

Job Category:
Business Enablement/Support

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for CAR-T Warehouse Change Control Analyst to be in Raritan, New Jersey.

Purpose: The CAR T Warehouse Change Control Analyst supports organization Change activities and is responsible for assessing the changes needs, impacts, and lead implementation activities.

You will be responsible for:


* Support process changes involving the CAR-T Warehouse.


* Support the change control process.


* Identify the needs of the warehouse and submit the request for a change control.


* Act as change control champion by being responsible for the change control prior to Initiation through completion.


* Participate in change control meetings.


* Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.


* Other duties will be assigned, as needed.

Qualifications / Requirements:

Education:


* Minimum of a Bachelor’s is required

Experience and Skills:

Required:


* Minimum two (2) years of relevant work experience


* Experience in Quality Assurance, Quality Systems, or Compliance


* Confirmed experience supporting change controls


* Practical knowledge in current Good Manufacturing Practices


* Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, and Outlook)


* Experience with COMET or equivalent system


* Strong interpersonal, written, verbal communication skills, and the ability to influence at all levels

Preferred:


* Experience with CAR-T cell and gene therapy


* Knowledge of National and International manufacturing regulatory requirements (e.g., FDA/EU)


* Familiarity with SAP, MES (electronic batch records), or equivalent systems

Other:


* Requires ability and flexibility to accommodate shift schedule (if needed) and unplann...